1. Field of the Invention (Technical Field)
The present invention relates to methods and devices for electrosurgery, including devices that operate in an electrolyzable media, including an aqueous electrolyzable media, by means of electrolysis and oxy-hydrogen combustion, and such devices with sensors and detectors for electrolysis and oxy-hydrogen combustion-specific parameters.
2. Description of Related Art
Note that the following discussion refers to a number of publications by author(s) and year of publication, and that due to recent publication dates certain publications are not to be considered as prior art vis-à-vis the present invention. Discussion of such publications herein is given for more complete background and is not to be construed as an admission that such publications are prior art for patentability determination purposes.
Electrosurgical devices have become widely popular for use in many medical treatment settings. However, limits in the ability to detect and measure the relevant parameters of the electrosurgical process have been known to impair the practitioner's ability to accurately and contemporaneously alter the electrosurgical application procedure to guard against treatment sequelae, induced iatrogenic damage, or to hinder the attainment of attaining treatment goals.
Although the need for such detection and measuring devices has been recently recognized, prior art contemplation and/or development of such devices has been limited to electrosurgical bulk property measurements such as temperature, fluid field impedance, and fluid field capacitance. This limitation has been due to both the inherent constraints in developing sensing and measuring devices within the foundation of the physiochemical paradigm of electrosurgery disclosed in the prior art, and to the perceived importance of such bulk property measurement for determining the extent and effect of electrosurgery.
As disclosed in U.S. patent application Ser. No. 10/119,671, electrosurgery has been incorrectly construed as being governed by plasma formation or related forms of ionization (see, e.g., U.S. Pat. Nos. 5,669,904, 6,206,878, 6,213,999, 6,135,998, 5,683,366, 5,697,882, 6,149,620, 6,241,723, 6,264,652, 6,322,549, 6,306,134 and 6,293,942, and the like), and this misconception has led to limited contemplation and development of detection and measuring devices for use during electrosurgical therapeutic applications. For example, in the plasma physiochemical paradigm of electrosurgery, it would be anticipated that detection and measuring devices would be contemplated and/or developed that require the use of instruments that can detect and measure the high energy emissions of plasma formation. Such emissions would include radiation elements such as free electrons, alpha particles, gamma particles, and x-rays. This approach has not been implemented, despite claims in the prior art that sufficient radiation signal intensity by means of a plasma is generated by the electrosurgical process, relative to normal background levels of radiation noise, necessary for treatment protocols and therapeutic effects. If sufficient radiation signal intensity is demonstrated, it would follow that useful detection and measuring devices could be developed with sensing and measuring algorithms for correlating these radiation measurements to treatment effects. However, this endeavor would require multivariate response surface modeling. Because modeling correlates currently exist only for highly idealized plasma generating environments utilizing vacuum chambers and/or magnetic field control, such detection and measuring devices have not been pursued. Extrapolating such ideal conditions to the in vivo application of electrosurgery methods and devices would prove insurmountable. For this reason, no further development of sensing and measuring devices of the electrosurgical process have been developed other than that of bulk property measurements; thus, plasma-related electrosurgical physiochemical paradigms have constrained the conceptualization and development of sensing and measuring devices for electrosurgery to those of the bulk property measurements as disclosed in prior art.
The perceived importance of bulk property measurement for determining the extent and effect of electrosurgery has been well documented. Quantifying energy input indirectly through temperature measurement, fluid field impedance measurement, and fluid field capacitance measurement is believed to indicated the degree to which electrosurgery will effect tissue and the host response thereof. Since such correlations have been extremely inconsistent in practice, a significant amount of confusion has surfaced regarding therapeutic electrosurgical protocols, often leading to the reduction in use of electrosurgical devices for certain applications. See, e.g., Thermometric determination of cartilage matrix temperatures during thermal chondroplasty: comparison of bipolar and monopolar radiofrequency devices. Arthroscopy, 2002 April; 18(4):339-46. The reliance upon bulk property measurements in developing therapeutic protocols incompletely addresses the true physiochemical processes of electrosurgery based upon the more detailed understanding of electrosurgery processes and phenomena described herein.
In the prior art, for example, temperature sensing devices have been disclosed that allow feedback measurement of the treatment environment temperature, such as referenced in U.S. Pat. Nos. 6,162,217, 5,122,137 and U.S. Published Patent Application 2001/0029369, and the like. These methods have been determined to be inaccurate due to the typically rapid changing milieu of the treatment locale. See, e.g., Radiofrequency energy-induced heating of bovine articular cartilage using a bipolar radiofrequency electrode. Am J Sports Med, 2000 September-October; 28(5):720-4. These devices do not accurately capture the multidimensional physiochemical occurrences of electrosurgery contemporaneously.
Further, fluid field impedance and fluid field capacitance sensing devices have been disclosed in prior art that allow feedback control of generator power output that drives the electrosurgical process, such as referenced in U.S. Pat. Nos. 6,306,134, 6,293,942, and the like. Energy delivery control is limited to these bulk properties which have yet to be accurately or completely correlated to the physiochemical governing relations of electrosurgery, and has proved to be too inaccurate relative to tissue response to serve as therapeutic benchmarking or controlling parameters.
However, as disclosed in U.S. patent application Ser. No. 10/119,671, the electrosurgical process is governed not by plasma or related forms of ionization but by electrolysis and oxy-hydro combustion. Therefore, development of electrosurgical devices and methods that are tailored to detect and measure the relevant parameters of electrolysis and oxy-hydro combustion are more appropriate and needed to enable desired treatment outcome. Clearly, there is a need for electrosurgical devices that are not only optimized to the true physical and chemical processes involved in the operation and use of such electrosurgical devices upon biologic tissue within safe energy spectra and power ranges, but also the need for the sensing and measurement of the true physiochemical occurrences of electrosurgery. Such devices will allow the more accurate and safe application of electromagnetic energy for electrosurgery to achieve intended outcomes.
Disclosed herein are two distinct means to accomplish these goals, which have heretofore not been contemplated or accomplished due to the lack of recognition of the electrolysis and oxy-hydro combustion process as inherent in electrosurgery: (1) the real-time simultaneous and contemporaneous detection and measurement of the relevant parameters of electrosurgery as described in the electrolysis and oxy-hydro combustion phenomena and (2) the placement of these detection and measurement devices within the surgical instrumentation itself, geographically juxtaposing sensing and measuring devices with treatment delivery devices, allowing for direct feedback of the treatment site to the medical practitioner.